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The purpose of this study is to determine if treatment with a single dose of RE104 for Injection reduces anxiety symptoms in participants with Generalized Anxiety Disorder (GAD) as compared to placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | A single subcutaneous injection of 0.9% sodium chloride for injection |
|
| 30 mg RE104 | Experimental | A single subcutaneous injection of 30 mg RE104 for Injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RE104 for Injection | Drug | Single, subcutaneous dose of RE104 for Injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| RE104 30 mg versus placebo change from Baseline at Week 4 in Hamilton Anxiety Rating Scale (HAM-A) total score | The Hamilton Rating Scale for Anxiety (HAM-A) is a 14-item scale that is used to rate the severity of symptoms of anxiety. The total score ranges from 0-56 with higher scores representing greater severity of anxiety. | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| RE104 30 mg versus placebo changes in total score from baseline in Hamilton Anxiety Rating Scale (HAM-A) | The Hamilton Rating Scale for Anxiety (HAM-A) is a 14-item scale that is used to rate the severity of symptoms of anxiety. The total score ranges from 0-56 with higher scores representing greater severity of anxiety. | Weeks 1, 2, 8 and 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mark Pollack Chief Medical Officer, M.D. | Contact | 1-888-880-REUN | info@reunionneuro.com |
| Name | Affiliation | Role |
|---|---|---|
| Mark Pollack, M.D. | Reunion Neuroscience Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lighthouse Psychiatry | Recruiting | Gilbert | Arizona | 85234 | United States |
Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.
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| Placebo |
| Drug |
Single, subcutaneous dose of 0.9% sodium chloride for injection |
|
| RE104 30 mg versus placebo percentage of participants with HAM-A response (≥50% reduction in score from Baseline) | The Hamilton Rating Scale for Anxiety (HAM-A) is a 14-item scale that is used to rate the severity of symptoms of anxiety. The total score ranges from 0-56 with higher scores representing greater severity of anxiety. | Weeks 1, 2, 4, 8 and 12 |
| RE104 30 mg versus placebo percentage of participants with HAM-A remission (total score ≤7) | The Hamilton Rating Scale for Anxiety (HAM-A) is a 14-item scale that is used to rate the severity of symptoms of anxiety. The total score ranges from 0-56 with higher scores representing greater severity of anxiety. | Day 1 and Weeks 1, 2, 4, 8 and 12 |
| RE104 30 mg versus placebo change from Baseline at Weeks 1, 2, 4, 8, and 12 in Hospital Anxiety and Depression Scale (HADS) depression subscore | The Hospital Anxiety and Depression Scale (HADS) is a self-reported scale measure the severity of depression and anxiety in patients with comorbid medical conditions. The scale consists of 14 items (7 for anxiety and 7 for depression), with a score ranging between 0 and 21 for the anxiety and depression subscales. | Weeks 1, 2, 4, 8 and 12 |
| RE104 30 mg versus placebo incidence of treatment-emergent adverse events (TEAEs) by frequency, severity and seriousness. | A treatment-emergent adverse event (TEAE) is defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a study drug. | From dosing through study completion (post-dose follow-up is for 12 weeks) |
| Preferred Research Partners, Inc. | Recruiting | Little Rock | Arkansas | 72211 | United States |
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| Collaborative Neuroscience Research, LLC | Recruiting | Garden Grove | California | 92845 | United States |
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| Kadima Neuropsychiatry Institute | Recruiting | La Jolla | California | 92037 | United States |
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| Open Mind Therapeutics | Recruiting | San Francisco | California | 94114 | United States |
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| TRIP Clinic at Psychedelic Science Institute | Recruiting | Santa Monica | California | 90404 | United States |
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| Innovative Clinical Research, Inc. | Recruiting | Lauderhill | Florida | 33319 | United States |
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| University of South Florida | Recruiting | Tampa | Florida | 33613 | United States |
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| Atlanta Center for Medical Research | Recruiting | Atlanta | Georgia | 30331 | United States |
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| CenExel iResearch, LLC | Recruiting | Decatur | Georgia | 30030 | United States |
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| Uptown Research Institute | Recruiting | Chicago | Illinois | 60640 | United States |
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| Henry Ford Medical Center - Columbus | Recruiting | Novi | Michigan | 48377 | United States |
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| Midwest Research Group | Recruiting | Saint Charles | Missouri | 63304 | United States |
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| UNM Research Program Psychedelic Therapies | Recruiting | Albuquerque | New Mexico | 14624 | United States |
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| NYU-H+C Clinical and Translational Science Institute | Recruiting | New York | New York | 10016 | United States |
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| Neuro-Behavioral Clinical Research, Inc. | Recruiting | North Canton | Ohio | 44720 | United States |
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| Summit Headlands LLC | Recruiting | Portland | Oregon | 97210 | United States |
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| Austin Clinical Trial Partners | Recruiting | Austin | Texas | 78737 | United States |
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| BioBehavioral Research Austion | Recruiting | Austin | Texas | 78759 | United States |
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| Aim Trials, LLC | Recruiting | Plano | Texas | 75093 | United States |
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| Cedar Clinical Research | Recruiting | Draper | Utah | 84020 | United States |
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| Inner Space State Street | Recruiting | Orem | Utah | 84058 | United States |
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| ID | Term |
|---|---|
| D000098647 | Generalized Anxiety Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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